• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device temporary non-roller type cardiac support blood pump
Definition A blood pump that provides temporary full or partial cardiac/ventricular support as an adjunctive therapy for patients considered high risk for cardiac procedures.
Physical State Rotor or axial type pump manufactured of various materials. Single use, disposable.
Technical Method pumps part or all of the patient's blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the heart to give it time to recover from an acute condition.
Target Area Heart
Review Panel Cardiovascular
Product CodeOZD
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
-
-